Herbal Supplements for Improvement of Liver Function in Participants With Alcoholic Liver Disease

Antioxidant for Improvement of Hepatic Function in Patients With Alcohol Liver Disease Without Cirrhosis: Non-randomized Interventional Cohort Study

Alcoholic liver disease represents the major health issues and it ranges from simple steatosis to cirrhosis. There is a paucity of data to support the allopathic intervention among these group of patients. Livitol-17 consist of the 3 whole herbs and extract which has antioxidant, hepatoprotective as well as reno-protective properties. The aim of this trial is to study the efficacy of herbal supplement to improve the liver function of alcoholic liver disease subject.

Study Overview

• Status: Not yet recruiting
• Conditions: Alcoholic Liver Disease
• Intervention / Treatment: Drug: Livitol-70

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alben Sigamani, MD; Phone Number: 8884431444; Email: alben.sigamani.dr@narayanahealth.org
• Study Contact Backup: Name: Sanjaya Chauhan, PharmD; Phone Number: 9611252350; Email: drsanjayachauhan49@gmail.com

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560099
      • Mazumdar Shaw Medical Centre
      • Contact: Alben Sigamani, MD; Phone Number: 8884431444; Email: alben.sigamani.dr@narayanahealth.org
      • Contact: Sanjaya Chauhan, PharmD; Phone Number: Chauhan 9611252350; Email: drsanjayachauhan49@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Adults aged over 18 years with the evidence of alcoholic liver disease (ALD) based on a thorough history, physical examination, and laboratory tests and all of the following:

• Chronic alcohol intake, Identified with AUDIT(Alcohol Use Disorder Inventory Test) Questionnaire
• Active alcohol use until 4 weeks prior to presentation
• ALT and AST elevated >1.5 times the upper limit of normal
• Over 1.5 ratio of AST to ALT
• Maddrey Discriminant function(DF) less than 30

Exclusion Criteria:

• Severe alcoholic hepatitis with cirrhosis or life expectancy less than 3 months
• Severe renal impairment (Glomerular filtration rate below 60 ml/min per 1.73m2)
• Hepatic disorders due to cardiac causes, inherited metabolic causes, hemochromatosis and Wilson's disease
• Participants with active viral hepatitis
• Under going active treatment for alcohol withdrawal syndrome(AWS) at the study entry
• Participants on hepatotoxic medications like antitubercular medication, antiviral medication, paracetamol etc.
• Pregnant, attempting to conceive, or lactating women
• Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; All the eligible participants will receive Livitol-17 capsules. It consist of 390 mg of whole herbs and extract of Phyllanthus niruri (Bhumyamalaki), Boerhaavia diffusa (Punarnava) and Picroorrhiza kurroa (Katuki).	Drug: Livitol-70; Livitol-17 detoxifies, purifies and rejuvenates liver, kidney and spleen. Participants will be given the intervention in two bottles at each visit. Participant will be instructed to take two capsule twice daily at a fixed time in the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in AST(Aspartate Aminotransferase)	The above mentioned test will be measured with panel of Liver function test at central laboratory.	3 months
Change from baseline in ALT(Alanine Aminotransferase)	The above mentioned test will be measured with panel of Liver function test at central laboratory.	3 months
Change from baseline in ALP(Alkaline Phosphatase)	The above mentioned test will be measured with panel of Liver function test at central laboratory.	3 months
Change from baseline in GGT(Gamma Glutamyl Transferase)	The above mentioned test will be measured with panel of Liver function test at central laboratory.	3 months
Change from baseline in serum total bilirubin	The above mentioned test will be measured with panel of Liver function test at central laboratory.	3 months
Number of Subject with adverse events	Adverse events is defined as any untoward medical occurrence that may not necessarily have a causal relationship with the treatment, but resulted in a dose reduction or discontinuation of treatment.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in radiological response	The degree of fatty infiltration will be assessed by ultrasound.	3 months
Change in maddrey discriminant function(DF)		3 months

Collaborators and Investigators

• Sponsor: Composite Interceptive Med Science
• Investigators: Principal Investigator: Alben Sigamani, MD, Narayana Hrudayalaya Hospital; Study Chair: Sanjaya Chauhan, PharmD, Composite Interceptive Med Science

Study record dates

Study Major Dates

• Study Start (Anticipated): May 30, 2018
• Primary Completion (Anticipated): October 30, 2018
• Study Completion (Anticipated): November 30, 2028

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 19, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol-Induced Disorders; Liver Diseases; Liver Diseases, Alcoholic
• Other Study ID Numbers: OI-009-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No